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FDA Obesity Work Group Knowledge Base Subgroup


Examples of Academic Research. Stanford Prevention Research Center. Modification of Social and Personal Factors ... Nickelodeon, and AOL Time Warner. Slide 23 ... – PowerPoint PPT presentation

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Title: FDA Obesity Work Group Knowledge Base Subgroup

FDA Obesity Work GroupKnowledge Base Subgroup
  • Richard Canady, Ph.D., DABT,
  • Corinna Sorenson, M.P.H., M.H.S.A.,
  • and Donna Robie Howard, Ph.D.
  • October 23, 2003

Examples of Academic Research
  • Stanford Prevention Research Center
  • Modification of Social and Personal Factors
  • Tufts School of Nutrition Science and Policy,
    Center on Nutrition Communication
  • Dissemination of Nutrition Information
  • Health and Nutrition Letter
  • University of Pennsylvania
  • Research Related to Nutrition and Prevention of

Example of Industry Activity
  • Kraft Foods
  • Worldwide Health Wellness Advisory Council
  • Guidelines for the Nutritional Characteristics of
    All Products
  • Limiting Portion Sizes on Single-Serving Packages
  • A Planned Effort to Help Improve Existing
    Products and Provide Alternative Choices, where
  • The Elimination of All In-School Marketing

Examples of Restaurant Activity
  • Wendys
  • Build a Meal
  • Tray Liners Ask for a Nutrition Guide
  • McDonalds Healthy Lifestyle Initiative
  • Menu Choices
  • Physical Activity
  • Education
  • Bag a McMeal

  • International Food Information Council
  • New Nutrition Conversation with Consumers
  • Kidnetic.com
  • Food Insight Newsletter
  • International Life Sciences Institute
  • Physical Activity and Nutrition (PAN) Program
  • Take 10TM!

Grocery Manufacturers of America
  • Incorporate Physical Activity and Nutrition
    Education in our Nations Schools
  • Encourage People to Incorporate Physical Activity
    in their Daily Lives
  • Educate the Public on the Connection between
    Calories Consumed and Calories Burned
  • Raise Consumer Awareness of Standardized Serving
  • Address the Needs of Different Population
  • Opposition to School Marketing Restriction

National Restaurant Association
  • According to the National Restaurant
    Association, science clearly proves that food
    cannot be, and is not, the sole culprit of the
    increasing rate of obesity in the U.S. Experts
    agree that this problem is fundamentally about
    energy balance-how much we eat in relation to how
    many calories we burn off each day.
  • National Restaurant Association Press Room,
    Fitness is Key to a Healthy Lifestyle,

Center for Science in the Public Interest
  • Have Historically Raised Issues Concerning
    Unhealthy Foods
  • Improving Your Diet and Health
  • 9 Weeks to a Perfect Diet
  • 10 Steps to a Healthy Diet
  • 10 Foods You Should Eat
  • 10 Foods You Should Never Eat

Center for Science in the Public Interest
  • Policy Options CSPI Suggests
  • Instructions to Take Action
  • What Action is Appropriate
  • School Foods Tool Kit
  • How to Improve School Foods and Beverages
  • Model Materials and Policies
  • Case Studies

Center for Consumer Freedom
  • Your Foods Under Attack
  • Consequences of Litigation against Restaurants
    and Industry
  • Consequences of Classifying Obesity as a Disease

  • California Soda Ban Signed into Law September
    2003 (Gov. Gray Davis)
  • DC Labeling Legislation (DC City Council Member
    Mendelson (D-At Large))
  • Florida Task Force (Gov. Jeb Bush (R))
  • NY Childhood Obesity Prevention Program
    Commercial Alert
  • Assemblyman Felix Ortiz (D-Brooklyn)

  • "Personal Responsibility in Food Consumption Act
    (Representative Keller (R-FL))
  • "Commonsense Consumption Act" (Senator McConnell
  • Restaurant Information Act of 2003
    (Representative DeLauro (D-CT))

  • John F. Banzhaf Seven Lawsuits Filed
  • Oreo Suit Dropped
  • Barber Suit Little Recent Activity
  • Pelman/Bradley Suit Dismissed
  • Obesity Policy Report, Volume I, Number 8 (June

Media - Periodicals
  • Time Magazine
  • October 20, 2003 The Secrets of Eating
  • September 2, 2002 What Really Makes You Fat?
  • U.S. News and World Report
  • June 16, 2003 The Truth about Weight Loss
  • August 19, 2002 SuperSize America

Media - Books
  • Amazon Search for Books on Diet 31,018
  • Amazon Search for Books on Weight Loss 1913
  • Atkins Diet
  • Dr. Phil McGraw
  • The South Beach Diet

Media Television
  • Food Network
  • Cooking Thin
  • Kathleen Daelemans
  • Lighten Up
  • Janette Barber and Christina Deyo
  • A Katie Couric Special September 12, 2003
  • Two Hour Special Dr Phil McGraw

Weight WatchersFlex Points System
  • Every Food Assigned a Point Value
  • Individuals Assessed and Given a Daily Point
  • Participants Allowed 35 Free Points a Week
  • Activity Points
  • Maintenance Program Once Goal is Reached
  • Recipes
  • Extensive QA on Website

Government Agencies Involved in Addressing
Obesity and Nutrition Issues
  • Department of Health and Human Services (DHHS)
  • Centers for Disease Control and Prevention (CDC)
  • National Institutes of Health (NIH)
  • Food and Drug Administration (FDA)
  • U.S. Department of Agriculture (USDA)

DHHS Initiatives Fostering Disease Prevention
and Health Promotion
  • Steps to a HealthierUS
  • New Initiative to Advance the Presidents
    HealthierUS goal
  • Priority Areas Include Obesity, Poor Nutrition,
    and Physical Inactivity
  • Healthy People 2010
  • Comprehensive Set of Disease Prevention/Health
    Promotion Objectives Developed to Improve the
    Health of All Americans
  • Healthfinder
  • Governments Premier Gateway Web Site Linking
    Consumers and Professionals to Over 60,000 Health
    Information Resources from the Federal Government
    and its Many Partners
  • National Health Information Center (NHIC)
  • National Health Information Infrastructure (NHII)

CDC Initiatives Focus on Improving Lifestyle
  • Regular Physical Activity is Such a Crucial
    Part of Good Health Our Goal is to Help People
    Understand that even Modest Activity Such as
    Walking is a Step in the Right Direction.
  • J. Gerberding, MD, MPH, Director, CDC

CDC Initiatives Focus on Improving Lifestyle
  • Trails for Health
  • Program to Help Americans Achieve the Health
    Benefits of Physical Activity by Increasing
    Opportunities for Physical Activity
  • Active Community Environments (ACES)
  • Initiative to Promote Walking, Bicycling, and the
    Development of Accessible Recreation Facilities
  • Personal Energy Plan (PEP)
  • 12-Week Self-Directed, Worksite Program to
    Promote Healthy Eating and Moderate Physical
  • Provides 40 to 60 Year-Old Women with the
    Knowledge and Skills to Improve Lifestyle Habits

CDC Initiatives Focus on Improving Lifestyle
  • Programs that Target Youth
  • KidsWalk-to-School
  • Community-Based Program that Encourages
    Individuals and Organizations to Work Together to
    Identify and Create Safe Walking Routes to School
  • VERB
  • Integrated Awareness Campaign to Encourage
    Positive Physical Activity among Youth Age 9-13
  • Media Partners Include Disney, Kids WB!,
    Nickelodeon, and AOL Time Warner

CDC Initiatives Focus on Improving Lifestyle
  • School Health Index
  • Self-Assessment and Planning Tool that Enables
    Schools to Identify the Strengths/Weaknesses of
    their Physical Activity and Nutrition
  • Other CDC Efforts
  • Health Program Funding
  • Research Programs
  • Surveillance Activities
  • Provision of Consumer Information

NIH Initiatives Combating Obesity a Precursor
to Chronic Disease
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Diabetes and Digestive and
    Kidney Diseases (NIDDKD)
  • NIH also Provides Relevant Information via
    MEDLINE and Supports Genetic Studies on
    Nutritional and Metabolic Diseases, Including

NIH Initiatives Combating Obesity a Precursor
to Chronic DiseaseNHLBI
  • Obesity Education Initiative (OEI)
  • Decade Old Education Program to Encourage the
    Adoption of Heart Healthy Eating Patterns and
    Physical Activity Habits
  • Population-Based Strategy
  • Risk-Based Strategy

NIH Initiatives Combating Obesity a Precursor
to Chronic DiseaseNIDDKD
  • National Task Force on Prevention and Treatment
    of Obesity
  • Leading Obesity Researchers and Clinicians
  • Weight-Control Information Network (WIN)
  • National Information Service for Health
    Professionals and Consumers
  • Sisters Together Move More, Eating Better
  • Designed to Encourage Black Women 18 and Over to
    Maintain a Healthy Weight
  • Other Relevant Activities Include a Consumer
    Information Website and Grant Programs to Advance
    Obesity/Nutrition-Related Research

NCI Initiatives Ensuring 5 A Day
  • NCIs Well-Known Nutrition Programs Strive to
    Increase the Intake of Fruits and Vegetables
  • 5 to 9 A Day
  • Program to Encourage Americans to Eat 5 or More
    Servings of Fruits and Vegetables Every Day for
    Better Health
  • In Collaboration with CDC and the Produce for
    Better Health Foundation
  • Men Shoot for 9
  • Initiative to Encourage Men to Eat 9 or More
    Servings of Fruits and Vegetables Every Day for
    Better Health
  • Mechanisms for Physical Activity Behavior Change

USDA Initiatives Aiming to Encourage Good
  • Interactive Healthy Eating Index (IHEI)
  • On-line Dietary Assessment Tool that Includes
    Nutrition Messages
  • Evaluates Dietary Intake as Compared to the Food
    Guide Pyramid
  • Website also Includes Recipes and Tips for
    Healthy Eating

USDA Initiatives Aiming to Encourage Good
NutritionFood Guide Pyramid
USDA Initiatives Aiming to Encourage Good
  • Nutrition and Your Health Dietary Guidelines for
  • Provides Advice for Americans 2 Years and Older
    about how Good Dietary Habits can Promote Health
    and Reduce Risk for Major Chronic Diseases
  • USDA Team Nutrition
  • Designed to Ensure the Effective Implementation
    of Healthy Breakfasts and Lunches in Schools

USDA Initiatives Aiming to Encourage Good
  • Eat Smart. Play Hard.
  • Education and Promotion Campaign to Combat
    Childhood Obesity and Chronic Diseases
  • Food and Nutrition Information Center
  • Website Includes Sections on Dietary Guidelines,
    Food Guide Pyramid, Food Composition, Dietary
    Supplements, Food Safety, and Healthy School Meals

USDA Initiatives Aiming to Encourage Good
  • USDA Programs Targeting Low-Income Children and
  • Farmers Market Nutrition Program
  • Program Expands the Awareness and Use of Farmers
  • Provides Fresh, Unprepared, Locally Grown Fruits
    and Vegetables to WIC Recipients
  • School Lunch Breakfast Program
  • Federally-Assisted Meal Program to Help Ensure
    that Children Engage in Healthy Eating Behaviors
  • Meals must Meet the Applicable Recommendations of
    the Dietary Guidelines for Americans

FDA Knowledge Base
  • Conceptual Grouping
  • Education
  • Regulation/Guidance
  • Enforcement
  • Research

1. Education
  • Know Your Label
  • Web-based video educational materials on how to
    use nutrition labels to make informed food
    choices in the context of a healthy diet.
  • Power of Choice
  • Guided activities and material to motivate and
    empower kids to make healthy food choices in
    real-life settings, topics include portion
    control, emotional eating, and individual
    fitness. (Recently completed collaborative effort
    with USDA/FNS)

1. Education
  • Food Label Content Relevant to Weight
  • Management
  • Standard reference serving sizes in nutrition
    facts panel
  • Facilitates counting calories while choosing
    nutritious foods, e.g., by comparing vitamins,
    minerals, and types of fats across products
    within a calorie range
  • Nutrient content claims
  • Based on standard criteria, help consumers make
    lower calorie choices when they see claims, like
    "reduced calories", "lite", "low calorie",
    "calorie free"

 1. Education
  • Dietary Guidelines
  • 2000 DGs include attention to healthy BMI,
    activity, eating sensibly, and portion size
  • Newly formed advisory committee is evaluating the
    need to update the DG's in 2005

2. Regulation/Guidance
  • Labeling/Packaging Effort
  • Research and development (stakeholder
    interaction, focus groups, and modeling) to
    develop label modifications or new approaches to
    labeling conducive to weight management. (More
    under research heading below)
  • Task Force on Consumer Health Information
  • for Better Nutrition
  • Framework to enhance conveyance of scientifically
    accurate information about the health
    consequences of foods.

2. Regulation/Guidance
  • Guidance for Industry on Clinical Development of
    Weight Loss Drugs
  • Efficacy criteria for approval of drugs for the
    treatment of obesity
  • Either, a statistically significant 5 or greater
    mean weight loss from baseline with drug relative
    to placebo
  • Or, a demonstration that the proportion of
    patients on drug who reach and maintain a weight
    loss of at least 5 from baseline is
    statistically significantly greater than the
    proportion who achieve the same on placebo

2. Regulation/Guidance
  • Guidance for Industry on Clinical Development of
    Weight Loss Drugs
  • Duration of trials
  • To establish durability of effect and to assess
    risks, FDA requires one year of placebo control
    with open-label extension through a second year

2. Regulation/Guidance
  • Drug Approvals
  • Two products marketed for chronic use in obesity
  • Orlistat (Xenical) an inhibitor of intestinal
    fat absorption
  • Sibutramine (Meridia) a serotonergic/sympathomime
    tic anorexigen
  • These are approved for patients with
  • BMI 27 with co-morbid conditions
  • and BMI 30 with or without co-morbid conditions

2. Regulation/Guidance
  • Devices Used for Obesity Treatment
  • Devices to restrict food intake or reduce hunger
  • Lap-band and similar gastric pouch restriction
    devices (only one approved specifically for
  • Other devices in investigational stage
  • Surgical devices for use with lipoplasty,
    gastroplasty, and bypass/diversion
  • Monitoring and measuring devices related to body
    composition (body fat)

2. Regulation/Guidance
  • Food Additive Approvals
  • Reduced or no-calorie sweeteners
  • Reduced or no-calorie fat substitutes

3. Enforcement
  • Enforcement and Compliance Activities
  • Labeling errors
  • Misleading claims
  • Unsafe products

4. Research
  • a) Communication/Labeling/Packaging
  • b) Effectiveness of Treatment/Prevention
  • c) Describing the Causal Links

4. Research
  • a) Communication/Labeling/Packaging
  • Evaluation of restaurant and food
    labeling/packaging effects on weight management
  • November 20 options-generating and data-gathering
  • Focus groups to probe new labeling/messaging
  • 3rd party industry interviews to identify
    potential obstacles or incentives to weight
    management messaging or products
  • Development of a social science model for
    exploring approaches to affecting weight
  • Research on consumer use of calorie content
    labeling and calorie-related claims

4. Research
  • b) Effectiveness of Treatment/Prevention
  • Pilot Cohort of dietary weight loss products
    used by women. Study pattern of use of herbal
    weight loss products by obese women the
    potential for herbal/drug product interactions
    and side effects

4. Research
  • c) Describing the Causal Links
  • Genetic polymorphisms of obesity in conjunction
    with susceptibility to breast cancer
  • Role of exercise in weight gain and
    susceptibility to mutation
  • Effect of surgical intervention on metabolism and
    biomarkers of reduced caloric intake
  • Animal model of lower-level dietary restriction
  • 10 dietary restriction increases lifespan and
    decreases cancer and other obesity-related
    diseases. What about 5?

4. Research
  • c) Describing the Causal Links
  • Contribution of methyl group deficiency induced
    by obesity to the development of cancer, heart
    disease and diabetes
  • Influence of developmental exposure to chemicals
    (e.g., tobacco smoke/nicotine) on childhood
  • Rat model for nutritionally induced non-insulin
    dependent diabetes mellitus (link to morbidity)
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